Device for dispensing muscle relaxant drugs



Oct. 25, 1960 r R HOLMES '2,957,609

DEVICE Foa nrsPEnsmG L1vf u sr.1a RELAXANT DRUGS Filed Nov. 6. 1958INVENTOR [llll Theodore R. Holmes BY M4. L

ATTORNEY DEVICE FOR DISPENSING `MUSCLE RELAXANT DRUGS Theodore R.Holmes, Tuckahoe, N.Y., assignor to Burronghs Wellcome & Co. (U.S.A.)111C-, Tuckahoe, N.Y., a corporation of New York Filed Nov. 6, 1958,Ser. No. 772,325

3 Claims. (Cl. Z22-212) The present invention relates to a novel devicefor dispensing muscle relaxant drug concentrates and to a method forpreparing injectable solutions of lsuch drugs by the transfer of thedrug concentrate from the storage receptacle to the solution bottleunder essentially aseptic conditions.

The method and device of the present invention is of particular value inconnection with the dispensing of drug concentrates in granular orpowder form from a sealed container in which it is stored in a'sterilecondition. Its application is illustrated in the preparation of sterilesolutions of muscle relaxant drugs such ,as succinyl choline for whichthe device and method are advantageously designed.

Succinyl choline is a muscle relaxant frequently administered byphysicians in the course of surgical operations. lt is a short actingdrug which `is considered a desirable safety factor and is ordinarilyadministered intravenously to the arm of the patient yfrom a suspendedsolution bottle in which it is stored. At the end of the operation theadministration of the muscle relaxant drug is discontinued and themuscles of the patient rapidly resume their normal tone.

Since drugs of this character depreciate in potency while in solution,it is advantageous to preserve them in the form of concentrates or drypowders until shortly prior to administration when the drug concentratesare added to aqueous solution in the proper concentration forintravenous administration. The diluents commonly employed for musclerelaxant drugs are isotonic saline solutions and saline solutionscontaining small quantities of glucose. The maintenance and preservationof these solutions under sterile conditions during storage and use is ofthe utmost importance.

Prepared sterile solutions of diluent in convenient volume are suppliedby a number of manufacturers, but the addition to such solutions of themuscle relaxant drug under absolutely aseptic conditions has presented asubstantial problem. One proposed solution consisted of packing thediluent under diminished pressure and providing the concentratecontainer with a hypodermic needle by means of which the transfer iseffected through puncture of a frangible diaphragm in the closure forthe diluent bottle. By these means the drug is automatically sucked intothe bottle of diluent and the solution thereby prepared foradministration. This method has not proven entirely satisfactory sinceit is still necessary to store the muscle relaxant in concentratedsolution form and the success of the mixing operation depends upon thepreservation of an accurate vacuum in the diluent container.

In a copending application Serial No. 756,998, I have described andclaimed a novel device for the storage of muscle relaxant drugs inessentially dry granular or powder form and a method whereby such drugsmay be transferred with certainty and under absolutely sterileconditions from the storage container to the diluent States Patent ifice bottle. These means include a collapsible container for the granularor powder muscle relaxant drug and a novel valve arrangement which opensunder the inuence of pressure applied to the collapsible container toallow the dry powder drug to flow through an elongated channel includinga piercing device through the stopper of the diluent infusion bottle andinto solution therein, while aseptically protected from the surroundingatmosphere.

The present invention constitutes an improvement over a preferred formof valve device shown in my aforementioned application which includes aplug type valve normally frictionally held in the valve opening formedin the upper portion of the Vvalve device.

Referring to the drawings wherein:

Figure 1 kis a vertical section through the vcollapsible container andassociated mechanism for the aseptic transfer of the concentrated drug,showing the improved arrangement which is the subject of this invention.

.Figure 2 shows the use of the novel valve arrangement in thepreparation of isotonic sterile solutions of the drug for intravenousadministration.

Figure 3 is a sectional view showing the relationship of the displacedplug or disc valve to the outlet channel in operation.

Figure 4 is a detailed showing of the construction of the valve devicewith the plug valve removed.

Referring in detail to the drawings, it will be observed that numeral 10designates a flexible plastic container 1 0 of polyethylene or similarmaterial with the neck portion provided with conventional threads 11 ofthe type for application of the 4screw cap. The collapsible container 10is provided with an external flange 12 having a series of knurls or lugsfor the retention of a plastic sealing band 18, the -details of whichare described in my copending application.

The neck of the bottle is adapted for the reception of an elastic valvedevice 13 of rubber, plastic or other similar material having adepending annular skirt portion 14 which is received in the neck portionof the collapsible container as clearly shown in Figure 1 of thedrawing. The upper portion of the valve device 13 is in the form of adisc of greater diameter than the skirt portion to provide a supportedledge for the valve device when positioned in the mouth of thecollapsible container. As shown in the drawings, an internally threadedpiercing device 16 is adapted to be threaded onto the mouth portion ofthe collapsible container 10 in such a manner that the outer flangededge of the valve device 13 is clamped between an annular shoulderformed internally above the threaded section of the piercing device andthe lip of the container mouth. A protective sheath of plastic or othermaterial 17 is positioned over the piercing device 16 and asepticallyseals the upper part of the assembly from contamination.

In the present construction the valve device 13 is provided with a plugtype valve 15 which may be in the form of a disc or any otherappropriate configuration. In the illustrated embodiment, the sides ofthe valve opening are sloped inwardly as illustrated in order topreclude accidental displacement of the valve from the central valveopening in the valve device 13. As shown in Figure 1, the `dome of thepiercing device 16 is formed with an integral inwardly directed n 19 asshown particularly in Figures 1, 2 and 3. v

When the physician or surgeon desires to prepare a sterile solution ofmuscle relaxant or other active drug for parenteraluse, the flexibleseal 18 and protective sheath 17 are removed thereby exposing thechannel piercing device 16. The collapsible container 10 for the drugconcentrate lis then inverted `and the frangible diaphragm 20 of aninfusion bottle 21 punctured by the piercing device 16 which thenprojects into the passage 22 of the infusion container 21.

The intentional application of pressure to the Walls of the collapsiblecontainer forces the pressure responsive valve plug to blow out of itsseat lin the valve device 13 coming to rest eventually at a slantedposition on the internal iin 19 in the dome of the piercing device 16 asshown 'in Figure 2 of the drawings. The powder or granular musclerelaxant drug then flows freely from the collapsible container 10through the open valve, the channeled piercing device 16 past thedisplaced plug valve 15 :and into the solution contained in the infusioncontainer 21 as clearly Shown in Figure 2 of the drawings. It will beobserved that the improved form of fin 19 tilts the displaced plug valve15 and prevents it from becoming centered and clogging the outletchannel in the piercing device.

In certain cases, infusion containers for the diluent infusible liquidare packaged under vacuum so that a subatmospheric pressure is presentin the dome of the bottle above the liquid. The purpose of thisprocedure is to accelerate the transfer of the drug concentrate from itscontainer into the infusion bottle 21. In such cases, it is onlynecessary to insert the channel piercing device 16 of the container 10into the inlet passage 22 of the infusion container. The vacuum in thecontainer then automatically snaps the valve plug 15 out of its seat,rapidly transferring the contents of the container through the channeledpiercing device 16 and into the infusion container 21 without manualapplication of pressure to the collapsible container 10.

Changes and modifications may be made within the specifically claimedembodiment without departing from the spirit and scope of the inventiondened in the claims.

Whatl claim is:

1. As an article of manufacture an internally sterile collapsiblecontainer having a dry comminuted drug concentrate partially filling thecontainer, and having an outlet `and a pressure-responsive removablestopper normally closing the outlet, said stopper being adapted to bepneumatically displaced outwardly to open the container outlet on theapplication of pressure to the collapsible container while inverted, adispensing channel for the container disposed exteriorly of thecontainer outlet through which the dry` drug concentrate is adapted toow after passing through the container outlet, a tilting device in thedispensing channel downstream of the container outlet `for tilting thestopper relative to the dispensing channel, after displacement from thecontainer outlet, to permit unrestricted Iflow of the dry comrninuteddrug concentrate through said dispensing channel.

2. As an article of manufacture an internally sterile container fortransfer of a drug concentrate to a parenteral diluent bottle, saidcontainer having a dry comminuted drug concentrate partially lling thecontainer and having an outlet and a pressure-responsive removablestopper normally closing the outlet, said stopper being adapted to bedisplaced outwardly to open the container outlet on the establishment ofa pneumatic pressure differential across the said stopper on inversionof the container, a dispensing channel for the container disposedexteriorly of the container outlet adapted for connection with aparenteral diluent bottle through which the dry drug concentrate isadapted to tow after passing through the container outlet, a tiltingdevice in the dispensing channel downstream of the container outlet fortilting the stopper relative to the dispensing channel, afterdisplacement from the container outlet, to permit unrestricted flow ofthe dry comminuted drug concentrate through said dispensing channel intothe parenteral bottle, and means for sealing the dispensing channel fromthe atmosphere during storage.

3. An article of manufacture as set forth in claim 2 wherein the tiltingdevice is an integral projection on the inside of the dispensingchannel.

References Cited in the le of this patent UNITED STATES PATENTS 489,620Widness Ian. 10, 1893 1,154,269 Penna Sept. 21, 1915 2,594,161 HarrisonApr. 22, 1952 2,724,383 Lockhart Nov. 22, 1955

